American Orthodontics: FDA filings under this applicant name

FDA lists 46 510(k) clearances under 2 spellings of the applicant name “American Orthodontics” (first 1989, latest 2026), across 14 product codes in 3 review panels. Median 510(k) review time under this name: 67 days. Since 2017 the median was 2 days, against 142 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name American Orthodontics took a median 2 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 142 days.

Top product codes

Plus 4 more product codes.

Review panels

• Dental (44)
• Gastroenterology and Urology (1)
• General Hospital (1)

Most recent American Orthodontics 510(k) clearances

36 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named American Orthodontics.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

FDA spellings included

FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:

• American Orthodontics (45)
• American Orthodontics Corp. (1)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• American Dade (149 510(k)s)
• American Edwards Laboratories (89 510(k)s)
• American Medical Systems, Inc. (82 510(k)s)
• American Bioproducts Co. (79 510(k)s)
• American Monitor Corp. (73 510(k)s)
• American Pharmaseal Div. Ahsc (64 510(k)s)
• American Bentley (59 510(k)s)
• American Hospital Supply Corp. (56 510(k)s)
• American Research Products Co. (56 510(k)s)
• American Diagnostic Corp. (39 510(k)s)
• American Laboratory Supply, Inc. (36 510(k)s)
• American Sterilizer Co. (36 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under American Orthodontics?

FDA lists 46 510(k) clearances under 2 spellings of the applicant name “American Orthodontics” (first 1989, latest 2026), across 14 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by American Orthodontics?

The median time from FDA receipt to decision across 510(k)s cleared under the name American Orthodontics is 67 days. Since 2017: 2 days, versus 142 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under American Orthodontics?

The most frequent FDA product codes under this applicant name are EJF (Bracket, Metal, Orthodontic, 22); DYH (Adhesive, Bracket And Tooth Conditioner, Resin, 8); NJM (Bracket, Ceramic, Orthodontic, 3).

Next steps

• See all 46 American Orthodontics clearances with predicates and recalls
• Run predicate analysis for product code EJF, American Orthodontics's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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